BEUDAMED
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    BELLEGLASS HP OPAQUE 2

    FDA 510(k)
    FDA Class 2 ·Dental

    STEVE MADDEN

    FDA UDI
    FGX INTERNATIONAL INC.·00193033482995·

    INSET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·January 13, 2026

    INSET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V·Product code FPA·January 21, 2026

    INSET

    FDA Adverse Event
    Injury ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·January 13, 2026

    CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    AESCULAP, INC., MONOSYN SYNTHETIC ABSORBABLE SURGICAL SUTURE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    10 MM HEMASHIELD ARTERIAL CANNULA

    FDA Adverse Event
    Malfunction ·ABIOMED, INC.·Product code DSQ·November 3, 2007

    0009613348-2025-013375

    FDA Adverse Event
    Injury ·INSTITUT STRAUMANN AG·Product code DZE·September 5, 2025

    CADD CASSETTE RESERVOIR

    FDA Adverse Event
    Malfunction ·ST PAUL·Product code FPA·January 7, 2021

    CADD CASSETTE RESERVOIR

    FDA Adverse Event
    Malfunction ·ST PAUL·Product code FPA·January 7, 2021

    FOUNDATION KNEE

    FDA Adverse Event
    ENCORE MEDICAL, L.P.·Product code JWH·March 20, 2013

    UNKNOWN ZIMMER FEMORAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·March 8, 2011

    KAPPA 700 DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code DXY·March 10, 2008

    CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·October 30, 2024

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014